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The purpose of this study is to obtain clinical experience with the use of new texture, round breast implants in bilateral primary breast augmentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Experimental | All participants who had new texture round breast implants surgically implanted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New texture round breast implants | Device | Breast implant surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Overall Satisfaction With the Device Using a 5-Point Scale | The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire | Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale. | 6 months |
| Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Heden | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxisklinik Siepe Friedrichstraße 57 | Bonn | 53111 | Germany | |||
| Malteser Krankenhaus |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants who had new texture round breast implants surgically implanted. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who had new texture round breast implants surgically implanted. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Investigator Overall Satisfaction With the Device Using a 5-Point Scale | The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device. | Full analysis population included all participants. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All participants who had new texture round breast implants surgically implanted. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device dislocation | General disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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The investigator examined the breasts and evaluated whether the implant was palpably distinguishable from the tissue using a 5-point scale where 1=implant very easy to distinguish from the tissue to 5=implant indistinguishable from the tissue. |
| 6 months |
| Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale | The investigator evaluated capsular contracture (lining of cells formed around the device as the body's response to a foreign object) using the Four-Grade Baker scale where: Grade I= Breast is normally soft and looks natural, Grade II= Breast is a little firm but looks normal, Grade III=Breast is firm and looks abnormal or Grade IV= Breast is hard, painful, and looks abnormal. The percentage of participants in each Baker Grade is reported. | Interim analysis: 12 months |
| Percentage of Participants With Local Complications | The percentage of participants experiencing local complications (in the area of the implant) is reported. | Interim analysis: 12 months |
| Bonn |
| 53123 |
| Germany |
| Akademikliniken 10 | Stockholm | 11542 | Sweden |
| Dolan Park Hospital | Birmingham | B60 1LY | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire | Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale. | Full analysis population included all participants. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue | The investigator examined the breasts and evaluated whether the implant was palpably distinguishable from the tissue using a 5-point scale where 1=implant very easy to distinguish from the tissue to 5=implant indistinguishable from the tissue. | Full analysis population included all participants. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale | The investigator evaluated capsular contracture (lining of cells formed around the device as the body's response to a foreign object) using the Four-Grade Baker scale where: Grade I= Breast is normally soft and looks natural, Grade II= Breast is a little firm but looks normal, Grade III=Breast is firm and looks abnormal or Grade IV= Breast is hard, painful, and looks abnormal. The percentage of participants in each Baker Grade is reported. | Full analysis population included all participants. | Posted | Number | percentage of participants | Interim analysis: 12 months |
|
|
|
| Secondary | Percentage of Participants With Local Complications | The percentage of participants experiencing local complications (in the area of the implant) is reported. | Full analysis population included all participants. | Posted | Number | percentage of participants | Interim analysis: 12 months |
|
|
|
| 2 |
| 18 |
| 18 |
| 18 |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Breast complication associated with device | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Genitourinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
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| Procedural headache | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
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| Breast cyst | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| Phlebitis superficial | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Measurements |
|---|---|
|
| Baker Grade IV |
|
| Measurements |
|---|
|
| Swelling |
|
| Other: Epitheliolysis |
|